The Ministry of Health is studying the specifics of Covid-19 self-tests to assess the implementation of this type of test in Brazil. Use in the country depends on registration and authorization by the National Health Surveillance Agency (Anvisa).
consulted by CNN, Anvisa reported this Tuesday (11) that it has not yet received the request for registration of the self-test by the Ministry of Health.
In accordance with the agency’s current rules, self-testing registration for compulsorily notifiable infectious-contagious diseases, such as Covid-19, can only be done if there is a public health policy and action strategy established by the Ministry of Health. self-tests for diabetes, HIV and pregnancy are allowed in the country.
Test evaluation criteria
The exams, which can be done at home, allow monitoring the conditions of the disease. However, the tests are not conclusive for the diagnosis according to Anvisa.
According to the agency, the use of self-tests as a public health measure must consider several aspects, including guidance on the use of tests by the population, safety measures, observation of limitations, warnings, care regarding storage, environmental conditions of the location to be used and reading interval.
“One should also take into account the impact related to possible errors in the execution of tests, which, in addition to impacting the quality of life of users, can affect public health programs”, Anvisa said in a note.
Population should receive instructions on the use
In an interview with CNN, cardiologist and intensivist Ludmila Hajjar defended the adoption of self-tests for Covid-19 in the country.
“With the self-test we want to increase the possibility of diagnosis for the population. For self-testing to be safe, we first need to teach the population, self-testing is simple by definition. The important thing is to have it released, approved, but that it trains the population”, he said.
For infectious disease specialist Renato Kfouri, director of the Brazilian Society of Immunizations (SBIm), the use of self-tests should be done with caution, and training is essential to avoid misinterpretation of the results.
“People may think they have the disease and they don’t. Or you think the result was a false negative. It is sometimes not simple to interpret these tests, especially if they are not collected properly,” Kfouri said in an interview with CNN.
Benefits in the context of public health
Since the beginning of the Covid-19 pandemic, in March 2020, testing has been pointed out by epidemiologists as a fundamental strategy for fighting the disease.
From the diagnosis and proper treatment of patients, it is possible to guide social distancing and promote the screening of other people who may have been exposed to the infection.
For researcher Cláudio Maierovitch, from the Oswaldo Cruz Foundation (Fiocruz), in Brasília, the use of self-tests as a public health strategy could bring benefits to the epidemiological context of the disease in the country.
“We could have an instrument placed by the government, free of charge, at the disposal of priority audiences, so that it would facilitate the identification of people with the virus, and isolation, quarantine and control measures would be practiced. This could make it safer to go back to school in public schools, for example,” he says.
For the researcher in health management at the Federal University of Rio de Janeiro (UFRJ), Chrystina Barros, the evaluation of the registration of self-tests also considers the protocols for notification of positive cases.
“The first point to consider is that if the test is positive, it does not turn it into a notification. It is an examination carried out in an unofficial way, both in the technical aspect and in the very condition of guaranteeing that the examination was carried out on that person. All notification requirements can only be guaranteed when you are in an institution that follows the flows, especially within an epidemic where notification is compulsory”, he says.
In an interview with CNN, the Minister of Health, Marcelo Queiroga, said that, if the tests are approved, there will be recommendations for the use and communication of the results to the health authorities.
“The Ministry of Health, through the Health Surveillance Secretariat and Secovid [Secretaria Extraordinária de Enfrentamento à Covid-19], will provide guidelines so that the results can be communicated and have the same effect as with regular testing”, said Queiroga.
Regarding the distribution of tests widely and free of charge, the minister said that the priority is testing with health professionals.
“From the point of view of a public policy for the federal government and the Ministry of Health to distribute these tests as a public policy, at the moment, what is a priority is to test with health professionals,” he said.
How self-tests work
Neurosurgeon and neuroscientist Fernando Gomes, from Hospital das Clínicas de São Paulo, explains that self-testing is a common methodology in medicine, such as measuring blood glucose for patients with diabetes or HIV and pregnancy tests. “It’s nothing very new when we talk about application for the large-scale population”, he said.
In the case of coronavirus, the patient who has the kit performs the collection through the secretion of the nose or mouth with a cotton swab. Subsequently, the rod is introduced into a chemical process and placed for testing. The result is available in about half an hour, indicating both a positive and a negative result for the presence of the virus.
Details on the use of the exams can be found in this Tuesday’s edition (11) of the Correspondent Medical section of the Novo Dia newspaper.
“There is biological safety, there are scientific works showing the efficiency of the test, but it is logical that there is human variation. Obviously, until now, this has been done by trained health professionals. But self-testing can indeed help with active behavior in terms of holding a person who is asymptomatic so that they do not pass the disease on to other people,” said Gomes.
Researcher Chrystina Barros, from UFRJ, states that the different technical specifications of each diagnostic kit need to be available in simple and accessible language.
“All these observations need to be made by the manufacturer according to each kit. This needs to be validated by the health surveillance to ensure that the product being placed on the market meets the technical specifications, the safety of the collection and the result in what is possible to achieve in this type of exam”, he said.
Self-testing is used as a public health strategy in the United States and in European countries, such as the United Kingdom, Portugal and Italy.
(With information from Fabrizio Neitzke, Larissa Rodrigues, Anna Gabriela Costa, Douglas Porto, Layane Serrano, Gustavo Uribe and Renata Souza, from CNN)
Reference: CNN Brasil
